Accelerating Data-Driven Drug Development Joshua a New @Jo - PowerPoint PPT Presentation

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG Accelerating Data-Driven Drug Development Joshua a New @Jo Joshua_a _a_ne _new Center for Dat ata a Innovat ation Septemb mber er 1 18, 2019

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG OV OVERV RVIEW 1. The Promise of Data-Driven Drug Development 2. Creating a National Health Research Data Exchange 3. Other Ways to Accelerate Drug Development with Data

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG THE PROMISE OF DATA-DRIVEN DRUG DEVELOPMENT Data-driven innovation is transforming every stage of the drug development lifecycle: discovery, clinical research, FDA review, and FDA post-market safety monitoring.

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG THE PROMISE OF DATA-DRIVEN DRUG DEVELOPMENT - DISCOVERY  Moving from analysis of existing remedies and serendipitous discovery to target-based discovery and high-throughput screening (HTS).  Making phenotypic screening more viable at scale.  Enabling i n silico screening. HTS assays. Source: University of Bergen

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG THE PROMISE OF DATA-DRIVEN DRUG DEVELOPMENT – CLINICAL RESEARCH  Improving patient recruitment with machine learning. Ensuring patients stay engaged and  complete trials successfully. Reducing side effects that cause  patients to exit a trial.  Decentralized and virtual trials. Source: U.S. Air Force

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG THE PROMISE OF DATA-DRIVEN DRUG DEVELOPMENT – FDA REVIEW  Bringing drugs to market faster with real-time data analysis.  The FDA’s Real-Time Oncology Review program approved breast cancer drug Kisqali just one month after submission. Source: FDA

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG THE PROMISE OF DATA-DRIVEN DRUG DEVELOPMENT – FDA POST-MARKET SAFETY MONITORING  FDA begins work on the Sentinel Initiative in 2007, launches the Sentinel System to cover hundreds of millions of patients in 2016. Analyzing data from EHRs, insurance  claims, and partners to monitor drug safety. Using real-world data (RWD) to  Source: WebMD support drug development.

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG CREATING A NATIONAL HEATLH RESEARCH DATA EXCHANGE  Access to data is a major barrier to data-driven drug development.  Patients want to share data, but often do not have the opportunity.  A National Health Research Data Exchange would solve these issues and be a boon to drug development, health care research, and public health.

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG CREATING A NATIONAL HEATLH RESEARCH DATA EXCHANGE  EHR integration Require National Health Research Data  Exchange API integration for EHR system eligibility for ONC certification.  Patient participation  Opt-out, rather than opt-in.  Option to donate data after death.  Data access Governed by a contractual model to guard  against misuse. Source: Johns Hopkins University  Unique identifiers Implemented as originally recommended in  HIPAA to ensure data integrity.

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG OTHER WAYS TO ACCELERATE DRUG DEVELOPMENT WITH DATA  Expanding access to institutional data  Expanding access to nontraditional data  Modernizing regulatory processes Promoting equity   “It’s hard to tailor treatments for people’s unique needs, if the people Source: STAT who are suffering from those diseases aren’t included in the studies.”  Developing AI skills

THE CENTER FOR DATA INNOVATION | DATAINNOVATION.ORG THA HANK YOU OU  Reports: “The Promise of Data-Driven Drug Development”  http://www2.datainnovation.org/2019-data-driven-drug- development.pdf  Email me: jnew@datainnovation.org